-The new safety data, as well as pre-clinical efficacy results,
presented at the Better Life for Coeliacs 2012 Conference
–

JERUSALEM--(BUSINESS WIRE)--September 10, 2012 07:00 AM Eastern
Daylight Time--BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a
biopharmaceutical development company, announced today that
BL-7010, an orally available treatment for celiac disease, was
found to be safe and well tolerated in pre-clinical studies
conducted to date. The new findings were delivered in an oral
presentation by Professor Elena Verdú, Division of
Gastroenterology, Department of Medicine, McMaster University,
Hamilton, Ontario, at the Better Life for Coeliacs 2012 Conference,
held in Helsinki, Finland from September 6th-9th. In her talk,
Prof. Verdú also presented previously disclosed pre-clinical
data demonstrating that BL-7010 reduces gluten toxicity, which were
published in the in leading medical journal Gastroenterology.

In pre-clinical studies BL-7010 was found to be safe, well
tolerated and did not cause any clinical adverse effects, even in
very high doses. Additional studies showed that BL-7010 is specific
to gliadins, the immunogenic peptides present in gluten that cause
celiac disease, and does not interact with non-related enzymes or
vitamins in the digestive tract. These results imply that BL-7010
will not affect the absorbance of vitamins or the digestion process
and therefore will not lead to malnutrition.

"These new findings for BL-7010, in addition to the pre-clinical
efficacy data are very encouraging, especially since BL-7010 was
found to be safe and without adverse effects in laboratory animals
even in doses much higher than the expected clinically effective
dose. Currently, the only effective treatment for celiac is a
gluten free diet, which is extremely difficult to maintain, and
significantly affects the quality of life of people with celiac
disease. Therefore, there is a critical need for developing a safe
and effective drug that could help, alongside the dietary
restrictions, in preventing damage caused to the digestive tract by
gluten," said Professor Elena Verdú, who presented the data.
"BL-7010 may attenuate the immune response to gluten and reduce
subsequent damage to the small intestine, and may therefore be an
effective adjuvant therapy that will improve the quality of life
for people with celiac disease throughout the world.”

Additional efficacy studies indicate that BL-7010 reduces
digestion of wheat gluten, thereby decreasing its toxicity. In
addition, BL-7010 attenuates the immune response to gluten in
rodents and prevents gluten-induced pathological damage to the
small intestine. BL-7010 is not absorbed systemically, indicating
its safety as a gluten-neutralizing substance. These data
demonstrate that BL-7010 has the potential to be an effective
adjunctive therapy to the gluten-free diet, to prevent or reduce
gluten-induced disorders in humans.

About BL-7010

BL-7010 is a novel, non-absorbable, orally available polymer
intended for the treatment of celiac disease and gluten
sensitivity. It has a high affinity for gliadins, the immunogenic
peptides present in gluten that cause celiac disease. By binding to
gliadins, BL-7010 effectively masks them from the immune system in
the digestive tract, and the BL-7010-gliadin complex is eventually
excreted from the digestive tract. This significantly reduces the
immune response triggered by gluten.

About Celiac Disease and Gluten Sensitivity

Celiac disease (CD) is a chronic, autoimmune, inflammatory
disease of the small intestine characterized by damage to the
lining of the small intestine and typically leads to dyspepsia,
malabsorption and a variety of other symptoms. It occurs in
genetically predisposed individuals and is caused by an
immunological reaction to gluten, found in wheat, barley and rye.
Estimates suggest that 1% of the world’s population is
affected by celiac disease, and prevalence is expected to increase
dramatically with improved diagnosis and awareness of the disease.
Today there are no pharmacological agents approved for CD and the
only treatment option is a life-long, strict, gluten-free diet,
which is difficult to maintain both due to food contamination with
gluten, as well as eating habits in a social setting. Non-celiac
gluten sensitivity is a common name for cases of gluten reactions
in which neither allergic nor autoimmune mechanisms are involved or
can be identified.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development
company. BioLineRx is dedicated to building a portfolio of products
for unmet medical needs or with advantages over currently available
therapies. BioLineRx’s current portfolio consists of six
clinical stage candidates: BL-1020 for schizophrenia is currently
undergoing a Phase II/III study; BL-1040, for prevention of
pathological cardiac remodeling following a myocardial infarction,
which has been out-licensed to Ikaria Inc., is currently undergoing
a pivotal CE-Mark registration trial; BL-5010 for non-surgical
removal of skin lesions has completed a Phase I/II study; BL-1021
for neuropathic pain is in Phase I development, BL-7040 for
treating inflammatory bowel disease (IBD) has commenced a Phase II
trial, and BL-8040 for treating acute myeloid leukemia (AML) has
completed Phase I. In addition, BioLineRx has nine products in
various pre-clinical development stages for a variety of
indications, including central nervous system diseases, infectious
diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules
mainly from biotechnological incubators and academic institutions.
The Company performs feasibility assessment studies and development
through pre-clinical and clinical stages, with partial funding from
the Israeli Government’s Office of the Chief Scientist (OCS).
The final stage includes partnering with medium and large
pharmaceutical companies for advanced clinical development (Phase
III) and commercialization. For more information on BioLineRx,
please visit www.biolinerx.com.

Various statements in this release concerning BioLineRx’s
future expectations, including specifically those related to the
development and commercialization of BL-7010, constitute
“forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
include words such as “may”, “expects”,
“anticipates”, “believes”, and
“intends”, and describe opinions about future events.
These forward-looking statements involve known and unknown risks
and uncertainties that may cause the actual results, performance or
achievements of BioLineRx to be materially different from any
future results, performance or achievements expressed or implied by
such forward-looking statements. Some of these risks are: changes
in relationships with collaborators; the impact of competitive
products and technological changes; risks relating to the
development of new products; and the ability to implement
technological improvements. These and other factors are more fully
discussed in the “Risk Factors” section of
BioLineRx’s most recent annual report on Form 20-F filed with
the Securities and Exchange Commission on March 22, 2012. In
addition, any forward-looking statements represent
BioLineRx’s views only as of the date of this release and
should not be relied upon as representing its views as of any
subsequent date. BioLineRx does not assume any obligation to update
any forward-looking statements unless required by law.